Adjustable pre-sutured allograft construct

ABSTRACT

A pre-sutured allograft construct and method of manufacture for repairing, replacing, reconstructing, or augmenting a hip or shoulder labrum may include a folded tissue portion extending from a first end to a second end and forming top, middle, and bottom folds. A stitched pattern secures the folded tissue portion into a graft roll having an overall length extending from a first adjustable region, through a central region, and through a second adjustable region. A continuous series of whip stitches extends from the first adjustable region, through the central region, and through the second adjustable region. A series of triple circumferential stitches overlays the whip stitches in the first and the second adjustable regions, while a series of circumferential stitches alternates with the whip stitches in the central region. The construct is pre-manufactured as an allograft product, but is adjustable during the surgical procedure within the body. Other embodiments are also disclosed.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This application claims the benefit under 35 U.S.C. 119 (e) of U.S.Provisional Pat. Application No. 63/169,991, filed Apr. 2, 2021 by RuthBledsoe, et al., for “SOFT TISSUE CONSTRUCT FOR SURGICAL USE AND METHODOF MAKING THEREOF,” which patent application is hereby incorporatedherein by reference.

BACKGROUND

An allograft includes bone, tendon, ligament, fascia, skin, or othertypes of tissue transplanted from one person to another. Allografts areused in a variety of medical treatments, such as knee and other jointreplacements, repairs, or augmentations, bone grafts, spinal fusions,eye surgery, and skin grafts for the severely burned. Allografts comefrom voluntarily donated human tissue obtained from deceaseddonor-derived, living-related, or living-unrelated donors and can helppatients regain mobility, restore function, enjoy a better quality oflife, and even save lives.

The labrum is a soft-tissue structure that lines and reinforces theball-and-socket joint of the shoulder and the hip. When the labrum istorn, frayed, or otherwise damaged as a result of injury,femoroacetabular impingement, or oftentimes as part of the agingprocess, a substitute fascia or soft-tissue graft may be used tosurgically repair, replace, or augment the damaged labrum.

Traditionally, a surgeon must accurately determine the required lengthof allograft fascia needed to replace the damaged portion of thepatient’s labrum (segmental or circumferential) prior to inserting theprepared graft into the joint space.. In addition, the preparation ofthe fascia graft is a labor-intensive undertaking for surgeons,meticulously suturing the graft to ensure a proper length,cross-sectional diameter, and maintaining the graft’s rigidity for eachpatient and/or circumstance, during the surgical procedure. Thesetechniques are complex and time consuming and difficult to achieve bothrepeatedly and consistently.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key aspects oressential aspects of the claimed subject matter. Moreover, this Summaryis not intended for use as an aid in determining the scope of theclaimed subject matter.

One embodiment provides a pre-sutured allograft construct for repairing,replacing, reconstructing, or augmenting a patient’s labrum. Theconstruct may include: (1) a folded tissue portion extending from afirst end to a second end, the folded tissue portion forming a top fold,a middle fold, and a bottom fold; and (2) a stitched pattern securingthe folded tissue portion into a graft roll having an overall lengthextending from a first adjustable region, through a central region, andthrough a second adjustable region, an adjustable length, and a fixeddiameter, wherein: (a) a continuous series of whip stitches extends fromthe first adjustable region, through the central region, and through thesecond adjustable region; (b) a series of triple circumferentialstitches overlays the continuous series of the whip stitches in thefirst and the second adjustable regions; and (c) a series ofcircumferential stitches alternates with the continuous series of thewhip stitches in the central region. The fixed diameter may be between5.0 mm and 5.5 mm or 5.5 mm and 6.0 mm. The overall length may beapproximately 6 cm, 10 cm, or 14 cm, and the adjustable length may bebetween 4 cm and 6 cm, 6 cm and 10 cm, or 10 cm and 14 cm.

Another embodiment provides a pre-sutured allograft construct forrepairing, replacing, reconstructing, or augmenting a patient’s labrum.The construct may include: (1) a tissue roll extending from a first endto a second end, the tissue roll including a top fold, a middle fold,and a bottom fold; and (2) a stitched pattern securing the tissue roll,the stitched pattern extending from a first adjustable region, through acentral region, and through a second adjustable region, wherein: (a)each of the first and the second adjustable regions comprises a seriesof triple circumferential stitches directly overlaying a correspondingseries of whip stitches; and (b) the central region comprises a seriesof circumferential stitches alternating with the series of the whipstitches.

Still another embodiment provides a pre-sutured allograft construct forrepairing, replacing, reconstructing, or augmenting a patient’s labrum.The construct may include: (1) a tissue roll extending from a first endto a second end; and (2) a stitched pattern securing the tissue roll,the stitched pattern extending through an adjustable region and anadjacent region, wherein: (a) the adjustable region comprises a seriesof triple circumferential stitches directly overlaying a correspondingseries of whip stitches; and (b) the adjacent region comprises a seriesof circumferential stitches alternating with the series of the whipstitches.

Other embodiments are also disclosed.

Additional objects, advantages and novel features of the technology willbe set forth in part in the description which follows, and in part willbecome more apparent to those skilled in the art upon examination of thefollowing, or may be learned from practice of the technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention,including the preferred embodiment, are described with reference to thefollowing figures, wherein like reference numerals refer to like partsthroughout the various views unless otherwise specified. Illustrativeembodiments of the invention are illustrated in the drawings, in which:

FIGS. 1A-1B illustrate respective top and detail views of a small sizedembodiment of a pre-sutured allograft construct;

FIGS. 2A-2B illustrate respective top and detail views of a medium sizedembodiment of a pre-sutured allograft construct;

FIGS. 3A-3B illustrate respective top and detail views of a large sizedembodiment of a pre-sutured allograft construct;

FIGS. 4A-4C, 4E-4Z, and 4AA illustrate the steps of an exemplary methodof manufacturing the embodiments of the pre-sutured allograft constructof FIGS. 1A-1B, 2A-2B, and 3A-3B; and

FIG. 5 illustrates the pre-sutured allograft with an overall lengthincluding adjustable regions and a center region.

DETAILED DESCRIPTION

Embodiments are described more fully below in sufficient detail toenable those skilled in the art to practice the system and method.However, embodiments may be implemented in many different forms andshould not be construed as being limited to the embodiments set forthherein. The following detailed description is, therefore, not to betaken in a limiting sense.

Various embodiments of the systems and methods described herein relateto a pre-sutured, soft-tissue matrix allograft construct, or apre-sutured construct, for the surgical replacement, reconstruction,repair, and/or augmentation of the labrum due to defects and tearsresulting from injury, degeneration, trauma, or disease. The pre-suturedconstructed is designed for placement into a labrum area that has beenresected, filling the area where tissue has been removed oraugmenting/repairing damaged labrum by reinforcement. Embodiments of thepre-sutured construct provide the surgeon practitioner with a mechanismto restore function and support after surgical intervention, improvingthe life of the patient while reducing operating time and complexity. Inaddition to reducing operating time with the patient on the operatingtable, a surgeon may work alone, without a second set of hands, to helpwith customization of the pre-sutured construct.

Embodiments of the pre-sutured construct may be formed from soft tissuessuch as, for example, fascia, tendon, or iliotibial band and may bepre-sutured into a cylindrical shape for ease of use. Embodiments of thepre-sutured construct may include three adjustable lengths (e.g., small,medium, large), each provided in two diameters to cover all potentialrequirements for replacement, repair, reconstruction, or augmentation ofthe labrum. The standard lengths cover segmental and circumferentialprocedures.

Embodiments of pre-sutured construct feature a pre-sutured pattern ofwhip and circumferential stitches that form five regions along a lengthof the allograft construct: two opposing end regions disposed at theoutermost ends of the allograft construct, two opposing adjustableregions disposed adjacent to and inward from the end regions, and onenon-adjustable central region disposed between the two adjustableregions. The suture pattern and associated suturing method result in apre-sutured allograft construct that holds its shape such that it may bepre-sutured and manufactured as a sterile allograft construct productthe surgeon orders, rather than sutures or prepares during the surgicalprocedure, and that features an adjustable length that may be adjustedprior or during the surgical procedure while it is being placed in thesurgical site.

Turning to exemplary embodiments, FIGS. 1A-1B illustrate top and detailviews of one embodiment of a pre-sutured construct 5. In this embodimentand as shown in FIG. 1A, the pre-sutured construct 5 has five regionsmoving from right to left, namely a first end region 10, a firstadjustable region 15, a central region 20, a second adjustable region25, and a second end region 30.

The pre-sutured construct 5 may be formed from an appropriate softtissue 35 such as, for example, fascia, tendon, or iliotibial band, andmay be manufactured in two diameters, a first diameter range of 5.0-5.5mm and a second diameter range of 5.5-6.0 mm. In this embodiment, thepre-sutured construct 5 is shown having a short length, or a length ofapproximately 80 mm end-to-end, with an approximate 40 mm central regionand 60 mm extending between the start of the first adjustable region 15and the end of the second adjustable region 25, rendering the shortpre-sutured construct 5 adjustable between approximately 40 mm and 60mm. As shown in FIG. 1B, and as discussed in detail below, the first andthe second adjustable regions 15, 25 may each comprise a series of whipand triple circumferential stitches 40, 40′, while the central region 20may comprise an alternating series of whip and central circumferentialstitches 45, 45′ bounded on each end by a partial circumferential stitch50.

Embodiments of the pre-sutured construct may be manufactured in anyreasonable and/or appropriate lengths so as to be applicable to all thepotential requirements for replacement, repair, reconstruction, oraugmentation of a labrum. For example, FIGS. 2A-2B illustrate apre-sutured construct 105 in a medium length of approximately 120 mmend-to-end, with an approximate 60 mm length of central region 20 and100 mm extending between the start of the first adjustable region 15 andthe end of the second adjustable region 25, rendering the mediumpre-sutured construct 105 adjustable between approximately 60 mm and 100mm. FIGS. 3A-3B illustrate a pre-sutured construct 205 in a large lengthof approximately 160 mm from end-to-end, with an approximate 100 mmlength of central region 20 and 140 mm extending between the start ofthe first adjustable region 15 and the end of the second adjustableregion 25, rendering the large pre-sutured construct 205 with anadjustable length between approximately 100 mm and 140 mm. In preparingthe various lengths of the pre-sutured construct, the triplecircumferential stitches 40′ of the first and the second adjustableregions 15, 25 and the alternating series of whip and centralcircumferential stitches 45, 45′ of the central region 20 may berepeated in any appropriate numbers, as appropriate and/or necessary, toachieve the desired length of each region. The medium pre-suturedconstruct 105 and large pre-sutured construct 205 may also be providedin two diameters of 5.0-5.5 mm and 5.5-6.0 mm, respectively.

FIGS. 4A-4C, 4E-4Z, and 4AA illustrate the steps of an exemplary methodof preparing an embodiment of the pre-sutured construct. Initially, themethod may begin with obtaining a tissue portion 400 (FIG. 4A) (e.g.,fascia) from a donor and evaluating the tissue portion for labrumreplacement, repair, reconstruction, and augmentation standards. Allexcess soft tissue (e.g., connective tissue) not removed duringcleansing may be removed prior to suturing.

Next, the technician may measure and cut the tissue portion into apre-formed shape such as a rectangle, which may include placing thetissue onto a cutting board such that the tissue portion lies flat andthe tissue fibers are oriented lengthwise (if applicable) relative to anallograft sizing board/block. Using the sizing board/block, thetechnician may measure and record a length of the tissue portion. Thislength measurement may be used to determine a size of the pre-suturedconstruct to be prepared, with minimum lengths, for example, of small at80 mm, medium at 120 mm, and large at 160 mm. Using a combination of thesizing block and a ruler, the tissue portion may be adjusted/measured toachieve a rolled diameter between 5.0 to less than 6.5 mm, as shown inFIG. 4A, before a sterile marker 405 can be used to indicate a trimline, as shown in FIG. 4B, and the excess tissue is trimmed to create atissue rectangle, shown in FIG. 4C, having front internal surface 410, aback external surface 415, a top edge 420, a bottom edge 425, a firstedge 430, a second edge 435, and a uniform thickness or diameter of5.0-6.5 mm when rolled.

Once cut into the pre-formed shape, the shape may be folded inpreparation for suturing. Using the tissue rectangle, the technician mayprepare a gate fold in the tissue by placing the tissue rectangle ontothe cutting board with the external side of the tissue (e.g., fascia)facing down before first folding the top and bottom edges into themiddle to form a gate fold 440, as shown in FIGS. 4E-4G, and thenfolding a now doubled bottom edge upward, leaving an approximate ¼ ofthe doubled tissue at the top uncovered or exposed to form an exposedfold portion 445 of a pre-folded graft 450, as shown in FIGS. 4H-4I.

Once folded into the pre-folded graft 450, the technician may initiatethe suturing process using a needle threaded with an appropriateflexible strand such as, for example, suture material of rope or wirethat is formed of natural or manmade materials that do not reactnegatively with human tissue. To begin, and as shown in FIG. 4J, thetechnician may suture a first construct end by inserting the needlethrough a back side of the exposed fold portion 445 of the pre-foldedgraft 450 at a point that is 3.0-5.0 mm from a first end (e.g., theright-side edge) of the pre-folded graft 450, through a front side ofthe of the exposed fold portion 445, and then creating a running stitch455 from a top end 460 to a bottom end 465 of the pre-folded graft byrepeatedly passing the needle through all layers of tissue.

Another running stich may then be created from the bottom end 465 to thetop end 460, without crossing the sutures on the back side of thepre-folded graft 450. Next, the sutures may be pulled tight to removeall slack from the stitches and to gather the tissue into a rolledposition, thereby forming a graft roll 470 having a bottom fold 475, amiddle fold 480, and a top fold 485, where the exposed fold portion ofthe pre-folded graft forms the top fold 485, as shown in FIG. 4K. Thesuture ends 490 may be tied at the front side of the graft roll 470 intoa square knot, with an additional knot to prevent sliding, to complete afirst end stitch 495.

The steps described above to form the first construct end may berepeated on the opposing end to form a second construct end with asecond end stitch 500, shown in FIG. 4L. In one embodiment and to assistwith the suture pattern discussed below, the technician may create adouble knot with the suture ends on both sides to form suture loops 55,as shown in FIGS. 1A, 2A, and 3A, such that the graft roll 470 may bepositioned onto a graft preparation board 505 by attaching the sutureloops to applicable and respective posts, with the top fold 485, andthus the exposed fold portion 445, positioned at the top, as shown inFIG. 4K. Suture loops 55 should be removed prior to implantation.

After completing the first and the second end stitches 495, 500, thetechnician may suture a whip stitch pattern along a length of the graftroll 470, beginning with the first adjustable region 15 and a first whipstitch 510 placed 5.0-10.0 mm inward from the end of tissue. To form thefirst whip stitch 510, the needle 515 may be passed into the graft roll470 from an outside of the bottom fold 475 to an inside of the bottomfold 475, ensuring the needle passes between the bottom and the middlefolds 475, 480 without piercing the middle fold, as shown in FIG. 4M.The suture 520 is pulled through, leaving 10.0-15.0 cm of a tail suture525 (FIG. 4N) remaining, before being passed under the top fold 485 andexiting through the outside of the top fold 485 in direct alignmentabove the previous stitch, as shown in FIG. 4N.

Next, the needle 515 may be wrapped over the front of the graft roll470, inserted through the outside of the bottom fold 475 adjacent to thetail suture 525, and passed through the bottom fold 475 to the insidebetween the bottom and the middle folds 480, 485, as shown in FIG. 4O,before the suture 525 is tightened to create a perpendicular stitch 530,or the first whip stitch 530 shown in FIG. 4P.

To continue the whip stitch pattern in the first adjustable region 15,the technician may insert the needle 515 a distance of 7 mm (± 1 mm)inward from the previous stitch before passing the needle 515 from thefront of the graft roll 470 under the top fold 485 between the middleand the top folds 480, 485, exiting through the outside of the top roll485, as shown in FIG. 4Q. The needle may then be wrapped over the frontof the graft roll 470, passed into the tissue through the outside of thebottom fold 475 in alignment with the previous stitch 535, and passedthrough the bottom fold 475 to the inside of the graft roll 470 betweenthe bottom and the middle folds 475, 480, as shown in FIG. 4R, beforethe suture 520 has slack removed to create a perpendicular stitch 540.The steps of inserting the needle through the top fold at the 7 mmoffset and passing the needle through the bottom fold in alignment withthe previous stitch may be repeated as necessary until the whip stitchesof the first adjustable region are complete, as required for the size ofallograft construct being manufactured:

Size No. of Stitches Offset; Length of Adjustable Region Small 3stitches 7 mm (± 1 mm); 12-16 mm total Medium 4 stitches 7 mm (± 1 mm);20-24 mm total Large 4 stitches 7 mm (± 1 mm); 20-24 mm total

For example, FIG. 4S shows four whip stitches 545 spanning approximately20 mm for a medium construct.

To continue the whip stitch pattern through the central region 20, thetechnician may insert the needle 9 mm (± 1 mm) beyond the previousstitch, or beyond the final whip stitch in the first adjustable region,before repeating the whip stitch pattern by passing the needle from thefront of the graft roll 470 under the top fold between the middle andthe top folds through to the outside of the top fold, wrapping over thefront of the graft roll, passing the needle through the outside of thebottom fold in alignment with the previous stitch, through the bottomfold to the inside of the graft roll between the bottom and the middlefolds, and tightening the suture to create a perpendicular stitch. Thispattern may be repeated until the whip stitches of the central regionare complete depending on the allograft construct size:

Size Central Region Length Small 35 mm - 41 mm Medium 55 mm - 61 mmLarge 95 mm - 101 mm

For example, FIG. 4T shows six (6) whip stitches 40 in the centralregion 20 (adjacent the first adjustable region 15) spanningapproximately 60 mm for a medium construct of the graft roll 470.

To complete the whip stitch pattern through the second adjustable region25, the technician may insert the needle 515 a distance 7 mm (± 1 mm)beyond the previous stitch 40, or beyond the final whip stitch in thecentral region, before repeating the whip stitch pattern by passing theneedle from the front of the graft roll 470 under the top fold 485between the middle and the top folds 480, 485 through to the outside ofthe top fold 485, wrapping over the front 550 of the graft roll 485,passing the needle 515 through the outside of the bottom fold 575 inalignment with the previous stitch, through the bottom fold to theinside of the graft roll between the bottom and the middle folds, andtightening the suture to create a perpendicular stitch. This pattern maybe repeated until the whip stitches 40 of the second adjustable region25 are complete depending on the allograft construct size:

Size No. of Stitches Offset; Length of Adjustable Region Small 3stitches 7 mm (± 1 mm); 12-16 mm total Medium 4 stitches 7 mm (± 1 mm);20-24 mm total Large 4 stitches 7 mm (± 1 mm); 20-24 mm total

On the final whip stitch, the needle 515 shall be passed from the front550 of the graft roll 470 under the top fold 485, exiting through theoutside of the top fold of the graft roll, as shown in FIG. 4U, beforethe tail suture 525 is secured and all of the whip stitches aretightened. Completion of the whip stitch pattern results in anintermediate allograft construct with a top 555, a bottom 560, the front550, and a back 565.

Once the whip stitch pattern is complete, the technician may stitch apattern of circumferential stitches 40′, working from the second endregion 30 adjacent to the final whip stitch, back through secondadjustable region 25, through the central region 30, and through thefirst adjustable region 15 to the first end region 10. The suturepattern may begin with a set of triple circumferential stitches 40′ inthe second adjustable region 25. To start, the technician may wrap thesuture 520 around the graft roll 470 over the final whip stitch,starting at the top of the intermediate allograft construct, andwrapping the suture 520 toward the back of the intermediate constructthree times, before passing the needle from the top of the intermediateconstruct towards a bottom of the intermediate construct at the adjacentwhip stitch, as shown in FIGS. 4V-4W, at which point the steps of triplewrapping the suture 520 and passing the needle 525 through theintermediate construct diagonally from the top of the intermediateconstruct towards the bottom of the construct at the next whip stitchmay be repeated until a requisite number of triple circumferentialstitches 40′ have been completed in the second adjustable region. In anembodiment, the first circumferential stitch 40′ is 3.0 wraps around thegraft 470. The second, third, and fourth (if applicable) are 3.5 wrapsbeing on the rough or sutured side:

Small 3 stitches Medium 4 stitches Large 4 stitches

For the final triple circumferential stitch in the second adjustableregion, the needle may be passed from the top of the intermediateconstruct and directed towards the bottom of the intermediate constructin a space between the last triple circumferential stitch and theadjacent whip stitch in the central region (not shown).

To form the circumferential stitches 45′ in the central region 20, thetechnician may begin with a partial circumferential stitch 50 bywrapping the suture 520 from the bottom to the top of the intermediateconstruct and passing the needle 515 from the top of the intermediateconstruct and through to the bottom of the intermediate construct in aspace between the next adjacent whip stitches (not shown). Thetechnician may then wrap the suture 520 around the intermediateconstruct, beginning at the bottom and wrapping towards the front oneand a half times, before passing the needle 515 from the top of theintermediate construct through to the bottom of the intermediateconstruct in a space between the next adjacent whip stitches, as shownin FIGS. 4X-4Y. This process of wrapping the suture 520 around theintermediate construct one and a half times before passing the needle515 from the top of the intermediate construct through to the spacebetween the next adjacent whip stitches may be repeated until stoppingwith the circumferential stitch 45′ prior to the final whip stitch 45 inthe central region. Then, a final partial circumferential stitch 50 maybe formed by wrapping the suture to the top of the intermediateconstruct (i.e., ½ wrap) and passing the needle 515 from the top of theintermediate construct through to the bottom of the adjacent whip stitch40 in the first adjustable region 15.

To complete the suture pattern, a set of triple circumferential stitches40′ may be formed in the first adjustable region. To start, thetechnician may wrap the suture 520 around the intermediate construct,starting at the top of the intermediate allograft construct, andwrapping the suture toward the back of the intermediate construct threetimes, before passing the needle 515 from the top of the intermediateconstruct towards a bottom of the intermediate construct at the adjacentwhip stitch 40 in the first adjustable region, similar to the formationof the triple circumferential stitches 40′ in the second adjustableregion 25, discussed above in relation to FIGS. 4V-4W. In an embodiment,the first circumferential stitch 40′ is 3.0 wraps around the graft 470.The second, third, and fourth (if applicable) are 3.5 wraps being on therough or sutured side: The steps of triple wrapping the suture andpassing the needle 515 through the intermediate construct diagonallyfrom the top of the intermediate construct towards the bottom of theconstruct at the next whip stitch 40 may be repeated until the triplecircumferential stitches 40′, and indeed the entire suture pattern, arecomplete, and in the last triple stitch 40′, the needle comes outadjacent to the tail suture 525:

Small 3 stitches Medium 4 stitches Large 4 stitches

For the final triple circumferential stitch 40′ in the first adjustableregion, the needle 515 may be passed from the top of the intermediateconstruct, straight through to the bottom of the intermediate construct,next to the tail suture 525.

To complete the suture process, the technician may tie the remainingleading suture to the tail suture 525 using a square or surgeon’s knot,repeating for a total of two knots. The tail suture 525 may then betrimmed before the needle is placed next to the surgeon’s knots and themain, leading suture is passed through the tissue to complete thepre-sutured allograft construct 5 shown in FIG. 4Z. Any remaining suturemay be trimmed. The completed pre-sutured allograft construct 5 may thenbe measured with a ruler for overall graft length between the outermostfirst and second end stitches, for a central length of thenon-adjustable central region between the first and second adjustableregions, and for a diameter using a sizing block 570, as shown in FIG.4AA:

Size 5-5.5 Passes through 5.5 but not 5 Size 5.5-6 Passes through 6 butnot 5.5

While small, medium, and large sized constructs are described above,embodiments of the pre-sutured allograft 5 construct may have anyappropriate overall length between 2 cm and 16 cm, may haveadjustability between 2 cm and 16 cm, and may have diameters rangingbetween 4 mm and 8 mm.

With reference to FIG. 5 , there is shown pre-suture allograft 5 with anoverall length 600 extending from adjustable region 15, through thelength of center region 20, and through adjustable region 25.

Once the suturing process and the pre-sutured allograft construct iscomplete, the pre-sutured construct 5 may be packaged and thensterilized using electron beam (E-beam) irradiation to sterilityassurance level (SAL) 10⁻⁶.

Embodiments of the pre-sutured allograft construct 5 described hereinmay be used in the surgical specialty of labrum repair, replacement,reconstruction, or augmentation in the hip or shoulder, and enable thesurgeon practitioner to order the pre-sutured, but adjustable, constructin preparation for surgery, rather than requiring him or her to preparea custom graft during the surgical procedure itself. Often, asmeasurement of a defect may be difficult, the pre-sutured, butadjustable, construct may be trimmed in place in the patient’s joint.Embodiments of the pre-sutured constructed may be adjusted in the body,during the procedure the additional compression of the graft caused bythe three circumferential stitches hold the diving suture (the suturethat passes from the top of one stitch through the graft to the bottomof the next) in place. When the graft is cut, the suture does notunravel due to the compressed surrounding tissue holding the suture inplace. This combines time and cost savings provided by the use of apre-sutured construct with maximum flexibility via the adjustable natureof the pre-sutured graft. This may be 30-40 minutes of operating roomtime as well as enhance patient safety with less time in the operatingroom. In addition to reducing operating time with the patient on theoperating table, a surgeon may work alone, without a second set ofhands, to help with customization of the pre-sutured construct assurgeons may find skilled technicians difficult to retain for customfabrication of custom grafts in the surgical theatre. The pre-suturedconstruct further provides reproducible results by providing aconsistent and functional graft construct.

Although the above embodiments have been described in language that isspecific to certain structures, elements, compositions, andmethodological steps, it is to be understood that the technology definedin the appended claims is not necessarily limited to the specificstructures, elements, compositions and/or steps described. Rather, thespecific aspects and steps are described as forms of implementing theclaimed technology. Since many embodiments of the technology can bepracticed without departing from the spirit and scope of the invention,the invention resides in the claims hereinafter appended.

What is claimed is: 1-20. (canceled)
 21. A pre-sutured allograftconstruct for repairing, replacing, reconstructing, or augmenting apatient’s labrum, comprising: a tissue portion extending from a firstend to a second end; and a stitched pattern securing the tissue portioninto a graft roll having an overall length, the graft roll having aselectively adjustable length, and the graft roll having a fixeddiameter, wherein: a series of whip stitches extends over at least aportion of the overall length; and a series of circumferential stitchesoverlays the series of the whip stitches.
 22. The pre-sutured allograftconstruct of claim 21, wherein the tissue portion extending from thefirst end to the second end is a folded tissue portion.
 23. Thepre-sutured allograft construct of claim 21, wherein the graft roll hasan adjustable region.
 24. The pre-sutured allograft construct of claim21, wherein the series of whip stitches is a continuous series of whipstitches.
 25. The pre-sutured allograft construct of claim 21, whereinthe whip stitches extend from an adjustable region through a centralregion.
 26. The pre-sutured allograft construct of claim 25, wherein aseries of circumferential stitches alternates with the series of thewhip stitches in the central region.
 27. The pre-sutured allograftconstruct of claim 21, wherein the series of circumferential stitches isa series of triple circumferential stitches.
 28. The pre-suturedallograft construct of claim 27, wherein the series of the whip stitchesis a continuous series of whip stitches, and wherein the series oftriple circumferential stitches overlays the continuous series of thewhip stitches.
 29. The pre-sutured allograft construct of claim 21,wherein the selectively adjustable length of the graft roll is providedby compression of the graft caused by the series of circumferentialstitches overlaying the whip stitches so as to allow a cut through thegraft roll, and the graft roll adjacent to the cut is configured toresist becoming unraveled in response to the compression provided by thetissue portion compressed by the series of circumferential stitchesholding the suture in place.
 30. The pre-sutured allograft construct ofclaim 29, further comprising a central region and an adjustable region,wherein the adjustable region in includes the series of circumferentialstitches overlaying the series of the whip stitches, and the graft rollis configured to allow the cut through the adjustable region and thegraft roll adjacent to the cut is configured to resist becomingunraveled in response to the compression provided by the tissue portioncompressed by the series of circumferential stitches holding the suturein place.
 31. A pre-sutured allograft construct for repairing,replacing, reconstructing, or augmenting a patient’s labrum, comprising:a tissue roll extending from a first end to a second end, the tissueroll including at least one fold; and a stitched pattern securing thetissue roll, the stitched pattern extending through an adjustableregion, wherein: the adjustable region comprises a series ofcircumferential stitches directly overlaying a corresponding series ofwhip stitches.
 32. The pre-sutured allograft construct of claim 31,wherein the at least one fold includes a top fold, a middle fold, and abottom fold.
 33. The pre-sutured allograft construct of claim 31,further comprising a central region adjacent the adjustable region, andthe central region comprises a series of circumferential stitchesalternating with the series of the whip stitches.
 34. The pre-suturedallograft construct of claim 31, wherein the adjustable region isprovided by compression caused by the series of circumferential stitchesoverlaying the whip stitches so as to allow a cut through the tissueroll in the adjustable region, and the tissue roll adjacent to the cutis configured to resist becoming unraveled in response to thecompression provided by the tissue portion compressed by the series oftriple circumferential stitches holding the suture in place.
 35. Thepre-sutured allograft construct of claim 31, wherein the series of whipstitches include partial whip stitches.
 36. A pre-sutured allograftconstruct for repairing, replacing, reconstructing, or augmenting apatient’s labrum, comprising: a tissue roll extending from a first endto a second end; and a stitched pattern securing the tissue roll, thestitched pattern extending through an adjustable region, wherein theadjustable region comprises a series of circumferential stitches. 37.The pre-sutured allograft construct of claim 36, wherein series ofcircumferential stitches of the adjustable region comprises a series oftriple circumferential stitches.
 38. The pre-sutured allograft constructof claim 36, wherein the adjustable region further comprises acorresponding series of whip stitches, and wherein the series ofcircumferential stitches directly overlays the corresponding series ofwhip stitches.
 39. The pre-sutured allograft construct of claim 36,further comprising an adjacent region to the adjustable region, theadjacent region comprises a series of circumferential stitchesalternating with the series of the whip stitches.
 40. The pre-suturedallograft construct of claim 36, wherein the series of circumferentialstitches of the adjustable region comprises a series of triplecircumferential stitches directly overlaying a corresponding series ofwhip stitches.